FDA Updates Articles
The Food and Drug Administration has revised its recommendations for testing blood donations for the Zika virus.
The U.S. Food and Drug Administration has approved Shire’s VONVENDI, a recombinant von Willebrand factor treatment for perioperative management of bleeding in adults 18 years and older with von Willebrand disease.
The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb), a biosimilar to Avastin (bevacizumab), the first biosimilar drug to treat cancer.
GlaxoSmithKline's Nucala (mepolizumab) has been approved by the U.S. Food and Drug Administration to treateosinophilic granulomatosis with polyangiitis (EGPA).
Abilify MyCite (aripiprazole tablets with sensor; Otsuka Pharmaceutical), the first digital ingestion tracking system, has been approved by the U.S. Food and Drug Administration.
CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear-off portion of the vial label.
The U.S. Food and Drug Administration has approved Agios Pharmaceuticals’ Idhifa (enasidenib) to treat acute myelogenous leukemia.
The U.S. Food and Drug Administration has approved CSL Behring’s Haegarda (C1 esterase inhibitor subcutaneous [human]), the first and only subcutaneous therapy indicated for routine prophylaxis to prevent hereditary angioedema attacks in adolescent and adult patients.
The U.S. Food and Drug Administration (FDA) has approved Privigen (immune globulin intravenous [human] 10% liquid) to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability.
The U.S. Food and Drug Administration has approved AbbieVie Inc.’s Mavyret (glecaprevir and pibrentasvir) to treat adults with certain types of hepatitis C.
The U.S. Food and Drug Administration has approved Kedrion Biopharma’s and Kamada’s KEDRAB (rabies immune globulin [human]) for passive, transient postexposure prophylaxis of rabies infection.
Novartis’ Kymriah (tisagenlecleucel) has been approved by the U.S. Food and Drug Administration to treat pediatric acute lymphoblastic leukemia.
